The Effects of COVID-19 Infection on Respiratory Muscle Strength and Core Stabilization

Sponsor
Yeditepe University (Other)
Overall Status
Completed
CT.gov ID
NCT05461391
Collaborator
Bezmialem Vakif University (Other)
50
1
3.5
14.2

Study Details

Study Description

Brief Summary

World Health Organization (WHO) Novel-19 Corrosion Disease (COVID) in 2019 without being used by a pathway caused by the SARS-CoV-2 virus. After the acute period in COVID-19 patients, muscle weakness may continue in breathing, weakness, and training. The primary muscle involved in calm breathing is the diaphragm. During inspiration, the diaphragm contracts, increasing the thorax volume and lowering the intrathoracic pressure, thus allowing air to enter the alveoli with the negative pressure effect. Expiration occurs passively with the relaxation of the diaphragm. Although the diaphragm is primarily known as the respiratory muscle, it also plays core stabilization. The proper functioning of the spine and proximal extremity muscles is essential in daily life, and spinal stabilization must function correctly. The diaphragm transverses the abdominus, pelvic floor, and multifidus forces in core stabilization. Muscle weakness in the diaphragm can affect respiratory function and core stabilization.The investigators aim to examine the relationship between respiratory muscle strength and core stabilization after COVID-19. In the literature, although the relationship between respiratory muscle strength and core stabilization has been demonstrated in previous studies, no study has been found on healthy adults who exercise regularly after COVID-19 infection. This relationship will be examined in this research, and the results will be presented. Thus, it is aimed that this study will guide the exercises to be added to the pulmonary rehabilitation programs after COVID-19 infection.The research will be implemented in Bezmialem Vakıf University Dragos Hospital Physical Therapy and Rehabilitation Units. Among our target group, the exercises with and without COVID-19 are training between 18-50.

No hypothesis (H0): Effects on core stabilization, respiratory functions, respiratory muscle strength, physical activity levels, and quality of life in healthy adults who do not have COVID-19 who do regular exercise, no difference compared to healthy adults who do regular exercise with COVID-19.

Hypothesis (H1): The effects on core stabilization, respiratory functions, respiratory muscle strength, physical activity levels and quality of life in healthy adults who do not have COVID-19 who do regular exercise may be higher than in healthy adults who do regular exercise with COVID-19.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The type of our study was planned as Case-Control. 50 exercises will be included in our study. The first COVID-19 (n= 25) is healthy, and the second group will come from the successful group without COVID-19 (n=25). Between February and April, a student will accept participating in the clinic at Bezmialem Foundation University. After being informed about it, the attached form will be signed. In addition, participants will be asked to fill in our attached document, including demographic and clinical studies, in a face-to-face interview. All body exercises, breathing muscle test, six-minute walking test, McGill core endurance test, short-form test, and quality of life test were planned in our two groups. The results of these tests will be evaluated by testing and checking.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    50 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    The Effects of COVID-19 Infection on Respiratory Muscle Strength and Core Stabilization in Healthy Individuals Who Exercise Regularly
    Actual Study Start Date :
    Mar 15, 2022
    Actual Primary Completion Date :
    May 15, 2022
    Actual Study Completion Date :
    Jun 30, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    Study Group

    Participants who got COVID-19.

    Control Group

    Healthy participants

    Outcome Measures

    Primary Outcome Measures

    1. Pulmonary Function Test [8 weeks]

      Medical International Research Spirodoc® Spiro spirometry will evaluate the respiratory functions of Italian brand volunteers. Lung function tests can determine both expected values and deviations of lung volumes. Spirometry has been used for over 150 years. Spirometry tests objectively evaluate both inspiratory and expiratory patients. The test will be repeated three times, and the best values will be recorded before and after the interventions.

    2. Respiratory Muscle Strength [8 weeks]

      Mikro Medical Micro RPM is aimed to measure Maximal Inspiratory Pressure (MIP) and Maximal Expiratory Pressure (MEP) values. During the application, maximum effort is requested, and the patient will be shown the test beforehand. During the measurement of MIP and MEP, it is closed with a nose clip, and after a deep breath, volunteers will be asked to give a maximum exhale for 1 to 3 seconds.

    3. Six Minute Walk Test (6MWT) [8 weeks]

      The 6MWT is a test that patients most commonly use, is valid, inexpensive, popular, easy to tolerate, easy to use, has minimal technological resources, and shows daily activity compared to other walking tests. They will be asked to walk at the same speed for 6 minutes, but not to run, on a 30-meter straight corridor. The volunteers' distance walked in 6 minutes will be calculated and evaluated.

    4. McGill Core Endurance Test [8 weeks]

      McGill Core Endurance Test consists of 4 different test positions. These positions are: trunk anterior flexor test, right and left lateral plank, and trunk posterior extensor. Before starting the trial, participants will be given a practice test. Our practice test is where they try to position their body correctly and stay static for a few seconds in each position. When we start the test, the patients will be asked to hold their positions for the maximum time, and three repetitions will be applied. The investigator visually determines the result of all tests to ensure test reliability. The investigator will use the "start" and "stop" commands to start and end the test. An assistant researcher will record the times using a stopwatch. Positions during testing will be randomly assigned.

    Secondary Outcome Measures

    1. International Physical Activity Questionnaire - Short Form (IPAQ-SF) [8 weeks]

      The IPAQ is the most widely used physical activity questionnaire to describe young and middle-aged adults (15-69 years) participation in physical activity. IPAQ-SF (short form) provides individual results for walking, moderate-intensity, and vigorous-intensity activity scores. The three physical activities' duration (in minutes) and frequency (in days) give the total score. Scores used for Mean Metabolic Task Equivalent (MET) values, total physical activity MET-minutes/week = Total walking + Moderate + Vigorous MET minutes/week scores. Survey questions will be asked to the participants face to face by the researcher, and the answers will be recorded.

    2. Quality of Life Scale (SF36) [8 weeks]

      It was planned to evaluate the quality of life of the volunteers with SF36. It includes measuring each of the eight multi-item health concepts, 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) social functioning, 5) general mental health problems, 6) role limitations due to emotional problems, 7 ) vitality (energy/fatigue) and 8) general health perceptions. Each scale is scored between 0-100; a higher score represents better quality of life. In addition, survey questions will be asked to the participants face to face by the researcher, and the answers will be recorded.

    3. Dyspnea Scale [8 weeks]

      The Modified Medical Research Council Scale (MMRC) is used to investigate the severity of dyspnea during activity in people with and without the disease. The MMRC is a five-item scale based on various activities that cause shortness of breath. Volunteers easily mark the activity level that causes dyspnea on the scale. The story of dyspnea in patients is graded from the "0" point, and the "0" point indicates the absence of dyspnea. The survey questions will be asked to the participants face to face by the researcher, and the answers will be recorded.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    1. To be between the ages of 18-50,

    2. Volunteering to participate in the research,

    3. Those who have done aerobic exercise at least three days a week in the last three months

    Exclusion Criteria:
    1. Neurological deficits in the upper or lower extremities,

    2. Fractures or orthopedic problems in the upper or lower extremities,

    3. Cardiovascular diseases that prevent rehabilitation,

    4. Systematic rheumatic disease (rheumatoid arthritis, ankylosing spondylitis),

    5. History of surgery in the last three months,

    6. Patients with spine problems,

    7. Smokers,

    8. Patients with chronic respiratory problems.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Bezmialem Vakif University Dragos Hospital Istanbul Maltepe Turkey

    Sponsors and Collaborators

    • Yeditepe University
    • Bezmialem Vakif University

    Investigators

    • Study Director: ildeniz yalnız, Bezmialem Vakif University Dragos Hospital
    • Principal Investigator: elif develi, Yeditepe University

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    İldeniz Yalnız, Physiotherapist, Yeditepe University
    ClinicalTrials.gov Identifier:
    NCT05461391
    Other Study ID Numbers:
    • yeditepe123
    First Posted:
    Jul 18, 2022
    Last Update Posted:
    Jul 18, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by İldeniz Yalnız, Physiotherapist, Yeditepe University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 18, 2022